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Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528395
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
Hospital La Fuenfría

Brief Summary:
Stroke creats dependancy of patients due to various associated impairments. The use of low-cost technologies for neurological rehabilitation may be beneficial for the treatment of these patients.

Condition or disease Intervention/treatment Phase
Stroke Other: Semi-immersive virtual reality Other: Conventional Rehabilitation Not Applicable

Detailed Description:

To determine the effectiveness of a structured protocol using semi-immersive virtual reality with commercial videogames for balance, postural control, functional independence, quality of life and motivation in patients who have suffered an ischemic and / or hemorrhagic stroke in subacute phase and are being treated in a mid-stay hospital.

Patients and methods: Randomized Controlled Trial. Simple blind. Control group will receive conventional therapy (physical therapy and occupational therapy) intervention being based on a task-oriented approach, with five weekly sessions of Physical Therapy and Occupational Therapy with duration of 45 minutes per session.

The experimental group will receive in addition to the above an experimental intervention during 8 weeks providing additional treatment using virtual reality semi-immersive complement is added by means of commercial video games implemented with the Xbox 360º video game console in conjunction with the Kinect device.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomly distributed to a control group or experimental group using the QuickCalcs application of GraphPad Software.

The following considerations will be taken into account:

Control group: 8 weeks of conventional rehabilitation based on a task-oriented approach. Consisting of five weekly sessions of physical therapy and of occupational therapy, lasting 45 minutes each.

Experimental group: 8 weeks of conventional rehabilitation provided identically as in the control group, plus virtual reality semi-immersive sessions. VR sessions will be applied following a protocol using commercial video games, three days a week (Monday, Wednesday and Friday) after the conventional rehabilitation sessions.

Masking: Single (Investigator)
Masking Description: All assessments will be made by blind evaluators with respect to the established study groups
Primary Purpose: Treatment
Official Title: Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation: Randomized Clinical Trial
Actual Study Start Date : May 20, 2017
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : March 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semi-immersive virtual reality
8 week protocol with semi-immersive virtual reality provided with the XBOX 360º video game console and its Kinect device. The commercial video games used will be: Kinect Sports I ®, Kinect Sport II ®, Kinect Joy Ride ® and Kinect Adventures ®.
Other: Semi-immersive virtual reality
Each participant will receive 24 additional sessions of semiinmersive virtual Reality therapy sessions on Monday, Wednesday and Friday, after realizing the conventional therapy sessions. The duration of each VR session will be gradually increased in time-intensity (5 minutes during the first week to 20 minutes during the last week) and motor requirements.
Other Name: Commercial video games

Active Comparator: Conventional Rehabilitation
Physical therapy and Occupational Therapy based on a task-oriented approach
Other: Conventional Rehabilitation
Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.
Other Name: Physical therapy and Occupational Therapy




Primary Outcome Measures :
  1. Timed get up and go [ Time Frame: eight weeks ]
    It is a test used to evaluate functional mobility and balance, adapted and translated into Spanish. The patient must get up from a chair, walk three meters in a straight line, turn and return to sit in the chair. The valuation is quantified from 1 to 5: 1- normal, and 5- fall hazard during the test. At present study was conducted supervised by two people that were placed laterally to the patient.


Secondary Outcome Measures :
  1. Tinetti scale [ Time Frame: eight weeks ]
    Scale validated in the context of stroke and whose score maximum for balance is 16 points, and 12 for gait. The higher the score, the lower risk of falls (less than 19 points on the scale total implies a high risk of falls; the risk is moderate with scores of 19 to 24).

  2. Baropodometry [ Time Frame: eight weeks ]
    The T-plate ® pedometer provides information on the pressure exerted by each point of the sole of the foot, distribution and plantar symmetry through a static test in the standing position. This test registers the center of pressures at a given moment, offering information on the distribution load (%) and the support surface.

  3. Static Posturography [ Time Frame: eight weeks ]
    Postural and static balance in standing was assessed through lateral and anteroposterior movement of the center of pressures in the x and y axes, in centimeters and square centimeters. Tests carried out were the Romberg test with open eyes, in which the patient remains on the platform and try to maintain balance during 30 seconds, and the Romberg test with eyes closed, in which the patient remains on the platform with closed eyes and tries to keep their balance for 30 seconds.

  4. Functional reach test [ Time Frame: eight weeks ]
    This test was used to detect alterations of the postural control and balance. The patient is placed standing holding the arm with the shoulder at 90 ° flexion, with a clenched fist, then realizes a maximum anterior reach without moving the feet of the ground. The maximum forwards distance without any supports is measured. A rigid tape measure with a leveler was used of a rule and bubble level calibrated bubble adhered to a mirror located on the wall. Patients able to perform this test were located with the healthy side next to the mirror, without direct contact. The result is registered in centimeters, measuring the distance between the initial and final position.

  5. Modified Rankin scale [ Time Frame: eight weeks ]
    Assesses the degree of physical disability after a stroke assigning a subjective score from 1 to 5. It is a very useful tool, validated and translated, to categorize functional level. It was used as a valuation tool pre and post intervention to describe changes in the level of functional independence of the patient after the experimental intervention.

  6. Barthel index [ Time Frame: eight weeks ]
    In order to assess functional independence, the Barthel index, indicated to evaluate the activities of daily life and validated in the Stroke context, translated and adapted to Spanish. It consists of 10 items with a range of score between 0 and 100 (with lower score, greater dependency).

  7. EQ-5D Questionnaire [ Time Frame: eight weeks ]
    The quality of life related to health was evaluated through the EuroQoL 5D. It is a test self-administered, generic, adapted to Spanish, in which health status is assessed in five dimensions (mobility, personal care, activities daily, pain / discomfort and anxiety / depression), and includes an optimal visual analog scale to assess the state of health at the time of registration (0-100).

  8. Cano-Mañas scale [ Time Frame: eight weeks ]
    The level of motivation, self-esteem and adherence to intervention was assessed using the Cano- Mañas. It is a Likert scale prepared by the research team and made since there is no validated instrument and translated that met the specific needs required. The first week of intervention was administered experimental and at the end of the eight weeks. It included 16 items (five motivation items, five of self-esteem and six of adhesion to the intervention). The scores were measured between 1 and 6: 1- very much in agreement; 5- strongly disagree; and 6-I have no opinion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with CVA in subacute ischemic or hemorrhagic type.
  • NIHSS scale score less than 20.
  • MoCA test with scores equal to or greater than 14 (mild cognitive impairment or absence of cognitive impairment).
  • Modified Rankin scale between 0-4.
  • Patients with the ability to maintain autonomous sitting and standing with or without aids.
  • Patients who have received the information document of the study and signed the informed consent form.

Exclusion Criteria:

  • NIHSS scale scores greater than 21 .
  • MoCA test with score lower than 14.
  • Modified Rankin scale between 5-6.
  • Patients without the ability to maintain autonomous sitting.
  • Patients who refused to sign the informed consent form.
  • Hospital discharge expected at the beginning of the study.
  • Patients who at any time have shown worsening of the general state, disinterest or desire to leave the study.

    • Pathologies susceptible to worsening or contraindication with virtual reality devices and commercial video games:

      • Photosensitive epilepsy.
      • Modified Ashworth scale greater than 2.
      • Moderate-severe cognitive impairment.
      • Visual alterations.
      • Non-collaborating patient.
      • Behavioral alterations.
      • Refusal to treatment with VR systems.
      • Presence of other neurological pathologies.
      • Other cardiovascular diseases that contraindicate physical exercise.
    • Visual or auditory, musculoskeletal, bone or joint alterations in acute or chronic phase that could influence the primary pathology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528395


Locations
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Spain
Hospital La Fuenfría
Cercedilla, Madrid, Spain, 28479
Sponsors and Collaborators
Hospital La Fuenfría
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: MªJosé Cano Mañas, PhD program Hospital La Fuenfría
Study Director: Roberto Cano de la Cuerda, PhD Universidad Rey Juan Carlos
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital La Fuenfría
ClinicalTrials.gov Identifier: NCT03528395    
Other Study ID Numbers: HP FUENFRÍA
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital La Fuenfría:
Balance
Baropodometry
Video games
Virtual reality
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases